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The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anterior cohort | Anterior Lumbar Interbody Fusion (ALIF) |
| |
| posterior cohort |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Lumbar Interbody Fusion (ALIF) | Procedure |
| ||
| Posterior Fusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oswestry Disability Index Score v2.1a | between pre-operative and 730 days (24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Pain Rating Scale (Pain NRS) for low back pain | between pre-operative and 730 days (24 months) | |
| Change in EQ-5D-3L health utility index | between pre-operative and 730 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Isthmic spondylolisthesis (IS)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143-0122 | United States | ||
| Carle Foundation Hospital |
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| Procedure |
|
|
| Urbana |
| Illinois |
| 61801 |
| United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Thomas Jefferson University / Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Utah Department of Orthopedics | Salt Lake City | Utah | 84108 | United States |
| University of Virginia Department of Neurosurgery | Charlottesville | Virginia | 22908 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |